Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05298306
Other study ID # LAT-NP-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 17, 2022
Est. completion date June 16, 2023

Study information

Verified date July 2023
Source Lateral Pharma Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule. Part B will evaluate the analgesic efficacy of a single intravenous dose of LAT8881, compared with placebo, in patients with lumbar radicular pain. Healthy volunteers are not accepted for Part B.


Description:

Part A of this study is a double-blind, randomized, placebo-controlled, single ascending dose study of intravenous administration of LAT8881 over 5 minutes in healthy volunteers. Eight participants will be enrolled. Each participant has three treatment days, 1 infusion per dosing day, on Days 1, 4 and 7 as well as two short visits for safety blood sampling on Days 3 and 6. Participants are randomised, so on each treatment day, 6 participants receive LAT8881 and 2 receive placebo (different participants to receive placebo each treatment day). LAT8881 doses administered are 0.8 mg/kg on Day 1, 1.2 mg/kg on Day 4 and 1.8 mg/kg on Day 7. Part B of this study is is a placebo-controlled randomized double blind cross-over safety and efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain. Participants will be randomly assigned to one of two groups, to receive either LAT8881 then placebo or placebo then LAT8881. Participants will receive a either single dose of LAT8881 [the Maximum Tolerated Dose from Part A of the study] or placebo via intravenous administration over 5 minutes on two consecutive days.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 16, 2023
Est. primary completion date May 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: For PART A, the following inclusion criteria apply: - Male or female healthy participants, aged 18-49 years inclusive at screening; - Body mass index of = 19.0 kg/m2 to = 32.0 kg/m2 at screening; - Female participants must not be pregnant or breastfeeding - Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment For PART B, the following key inclusion criteria apply: - Male or female participants with unilateral pain, aged 18 years and above at screening; - Body mass index of = 19.0 kg/m2 at screening. - Female participants must not be pregnant or breastfeeding - Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment - Presenting with a history of unilateral pain, radiating into a lower limb, of lancinating, burning, stabbing or electric quality, of duration of >3 months. - Pain scores (VAS) for average daily leg pain at rest at the relevant nerve root of a mean of =4/10 and =9/10 for 3 days prior to treatment, with a minimum of >3/10 on any day. - Demonstration of disc herniation within 6 months by CT or MRI at a segmental level consistent with the clinical features. - The site of disc herniation must affect L1-2, L2-3, L3-4, L4-5 or L5-S1. - The patient is willing to keep all analgesic medication and other therapy usage stable or decreased in the week prior to, and a week after, IP administration. - The patient is in good general health, with the exception of the presenting condition under study Key Exclusion Criteria: The following key exclusion criteria apply for both PART A and PART B: - Any condition which might be a risk to participant safety or interfere with study evaluation - Unwillingness to abstain from alcohol or nicotine products as required The following additional key exclusion criteria apply to PART B: - A history of significant pain unrelated to disc herniation that would significantly compromise assessment of leg radicular pain. - Radiological evidence of foraminal stenosis or of clinically significant spinal stenosis . - Lumbar back surgery related to the specific disc. - Injection of an epidural corticosteroid injection within 3 months of screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LAT8881
In Part A, LAT8881 will be given as a single intravenous infusion at doses of 0.8, 1.2 and 1.8 mg/kg. In Part B, a single intravenous infusion of LAT8881 will be given, the dose to be determined by the results in Part A
Placebo
Matching placebo'given as a single intravenous infusion at all dose levels

Locations

Country Name City State
Australia PARC Clinical Research Adelaide South Australia

Sponsors (2)

Lead Sponsor Collaborator
Lateral Pharma Pty Ltd Southern Star Research Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with adverse events by dose (Part A) The number of participants in Part A with the following adverse events will be reported by dose (with all placebo subjects combined)
All adverse events
Serious adverse events
Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP)
Adverse events by intensity
Adverse events by relationship to IMP
From first dose of LAT8881 to end of study visit (Day 14)
Primary Change in baseline pain with intravenous LAT8881 in patients with lumbar radicular pain (Part B) Change in pain from baseline is measured on on a 0-10 Visual Analogue Scale (VAS). The VAS consists of a 10 cm line with two endpoints representing 0 (no pain) and 10 (pain as bad as it could possibly be). The subject is asked to rate their current level of pain by placing a mark on the line and the distance from 0 is measured to provide a pain intensity score out of 10.
VAS measurements are taken as the infusion starts and at 15 minute intervals for the first hour, then every thirty minutes for an additional two hours, then hourly until 6 hours from infusion commencement
From start of infusion to 6 hours after start of infusion
Secondary Maximum plasma LAT8881 concentration (Cmax) after intravenous LAT8881 (Part A) LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration Up to 6 hours after the start of each infusion
Secondary Time to maximum plasma LAT8881 concentration (Tmax) after intravenous LAT8881 (Part A) LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration Up to 6 hours after the start of each infusion
Secondary Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) after intravenous LAT8881 (Part A) LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. (AUC0-inf) will only be calculated if there are at least three quantifiable data points Up to 6 hours after the start of each infusion
Secondary Terminal elimination half life (T1/2), (Part A) LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. The terminal elimination half life will only be determined if there are at least three quantifiable elimination phase data points. Up to 6 hours after the start of each infusion
Secondary Patient general impression of change (Part B) The Patient General Impression of Change (PGIC) is a a single-item rating by subjects of their improvement with treatment during a clinical trial. It asks the subject to rate their improvement with therapy on a 7-point scale, ranging from substantially worse ("0") to substantially improved ("7"), with no change ("4") as the mid-point. A score above 4 indicates an improvement. 6 hours after the start of the second infusion
Secondary The number of participants with adverse events after intravenous LAT8881 in patients with lumbar radicular pain (Part B) The number of participants in Part B with the following adverse events will be reported after placebo and after intravenous LAT8881
All adverse events
Serious adverse events
Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP)
Adverse events by intensity
Adverse events by relationship to IMP
From start of infusion to end of study visit (Day 9)
See also
  Status Clinical Trial Phase
Recruiting NCT05923736 - Cardiovascular Risk in Digital Osteoarthritis N/A
Completed NCT05003726 - Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation N/A
Completed NCT05556538 - The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
Recruiting NCT06143813 - Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade N/A
Completed NCT04701879 - Spinal Decompression Therapy in Radicular Chronic Low Back Pain N/A
Active, not recruiting NCT05719792 - Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections
Enrolling by invitation NCT06151704 - The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation N/A
Not yet recruiting NCT05793528 - The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection
Not yet recruiting NCT06275529 - Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification N/A
Recruiting NCT05261581 - Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy Early Phase 1
Completed NCT03894943 - Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation N/A
Completed NCT05571046 - Glucocorticoid Injection in Patients With Lumbar Radicular Pain Phase 4
Recruiting NCT04054401 - SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study N/A
Completed NCT04224077 - Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) N/A
Not yet recruiting NCT05729022 - Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections N/A
Terminated NCT03801356 - Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy Phase 4
Recruiting NCT03502057 - P-15L Bone Graft Lumbar Fusion Clinical Trial N/A
Completed NCT04695912 - The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back N/A
Recruiting NCT06421558 - Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy N/A
Completed NCT04276519 - Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation N/A